Per Diem Clinical Research Coordinator II - Riverside, CA

Syneos Health • Morrisville, NC

166d

About The Position

Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives.

Requirements

• Experience in clinical research coordination.
• Knowledge of Good Clinical Practices (GCP).
• Ability to manage multiple clinical trials simultaneously.
• Strong organizational and communication skills.
• Ability to work flexible hours including days, afternoons, nights, and weekends.

Nice To Haves

• Experience with regulatory submissions.
• Familiarity with clinical trial management systems.
• Previous experience in patient recruitment.

Responsibilities

• Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.
• Prepare and maintain the Investigator Site File and/or Trial Master File (TMF) for the study.
• Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings).
• Take the lead and/or overall coordination of all required start-up activities including clinic logistics planning, schedule of clinic activities, and team training.
• Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials.
• In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
• Confirms all required regulatory and contractual documentation is present prior to study start.
• Support the Principal Investigator as needed with study related tasks such as Delegation of Authority Log and management of daily tasks.
• Advertise, recruit, and screen potential participants for the study.
• Perform all study activities following Good Clinical Practices (GCP).
• Manage multiple clinical trials simultaneously.
• Protect the safety of human subjects.
• Monitor appropriate sources for specific clinical study or federal regulation updates.
• Collect and enter study data into the appropriate system.
• Coordinate and monitor screening activities; provides support as required.
• Assist with informed consent of study subjects.
• Submit data in required timeframe.
• Complete Case Report Forms.
• Facilitate audits of study data.
• Develop patient rapport to explain research protocols and minimize protocol violations.
• Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable.
• Screens eligibility prior to randomization; oversees, coordinates and/or performs study drug administration, and other activities as delegated and required.
• Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings.
• Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.
• Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation.
• Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.).
• Responsible for monitoring subjects' compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate.
• Prepare for and participate in sponsor/monitor/QA audits.
• Provide accurate and timely project status updates to Project Managers and sponsor.
• Collaborate within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals.
• Accommodate flexible schedule (available days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.
• Maintain proper protocol, consent, amendment, and yearly renewal submission if requested.
• Report adverse events relating to the trial.
• Maintain study files.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services